Sympathomimetic Agent
Ephedrine for Childbirth
Icahn School of Medicine at Mount SInai, New York, NY
Ephedrine +1 morePhase 4RecruitingResearch Sponsored by Icahn School of Medicine at Mount SinaiEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Category 1 fetal tracing prior to placement of neuraxial anesthesia
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow upsday 1, 30 minutes after administration of intrathecal opiate
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Study Summary
This trial will study if ephedrine given before epidural anesthesia placement can reduce the number of Category II fetal heart rate tracings and low blood pressure due to labor analgesia.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Before receiving certain types of anesthesia, the baby's heart rate should be checked and should be normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow ups ~ day 1, 30 minutes after administration of intrathecal opiate
Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ day 1, 30 minutes after administration of intrathecal opiate
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of category II fetal heart rate tracing
Secondary outcome measures
Average HR changes
Average blood pressure changes
Incidence of antihypertensive treatment after ephedrine administration
+7 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EphedrineExperimental Treatment1 Intervention
3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 7.5 mg ephedrine IV will be administered to the patient, 12 minutes later, a second dose of 7.5mg will be administered to the patient as long as the patient is not hypertensive (BP no greater than 140/90)
Group II: PlaceboPlacebo Group1 Intervention
3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 2.5cc 0.9% NS IV will be administered to the patient, 12 minutes later, a second dose of , 2.5cc 0.9% NS will be administered to the patient.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ephedrine
2016
Completed Phase 4
~26810
Find a site
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
816 Previous Clinical Trials
510,739 Total Patients Enrolled
James LeaderStudy Director
Icahn School of Medicine at Mount SinaiMedia Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical experiment accept applicants over the age of eighty?
"This medical study is open to individuals aged 18-55."
Answered by AI
Is there an opportunity to participate in this medical research?
"To be eligible, candidates of child-bearing age (18 to 55) are encouraged to apply. The research team aims to enrol 150 participants in total."
Answered by AI
Are there any adverse effects associated with Ephedrine use?
"Given the fact that this is a Phase 4 clinical trial, our team at Power has rated ephedrine's safety as 3. This signifies that it has been sanctioned for use by medical professionals."
Answered by AI
Are there still available slots for participants in this medical experiment?
"According to information obtained from clinicaltrials.gov, this medical trial is not actively accepting applications at present. Inaugurated on May 1st 2023 and last updated 23 days later, the trail has ceased recruiting patients for now; yet four other studies are still in search of volunteers."
Answered by AI